Mineral Salts Low in Endotoxins for parenteral Medicines

Endotoxins are lipopolysaccharides (LPS) which are outer membrane components of gram-negative bacteria. By decomposing, these bacteria release lipopolysaccharides, which are toxic.

Parenteral medicines such as solutions for dialysis, hemofiltration and osmotherapy constitute a marked quality standard. Systemic parenteral application of infusions or injections with endotoxin quantities as low as 0.1 ng per kilogram of bodyweight can cause various physiological reactions, including fever, inflammation and sickness behavior in humans and animals. Due to the high sensitive application form, the manufacture of parenteral medicines requires particular caution: it is subject to strict and specific regulatory requirements and is regulated by Chapter 2.6.14 of the European Pharmacopoeia (Ph.Eur.). In order to support manufacturers of parenteral products to comply with legal and quality requirements, Dr. Paul Lohmann® offers Mineral Salts with a very low content of endotoxins.

Within the biotech industry, Low in Endotoxin qualities are of special interest for cell cultures. Endotoxins can cause undesirable effects on cell proliferation or cell function. Due to the high purity of our products, highly sensitive cell lines can develop in an optimal and laboratory controlled environment.

Low in Endotoxin Qualities of Dr. Paul Lohmann® Products

In 2017, a purpose-built plant was brought into service. This plant is GMP-certified and solely dedicated for the production of low endotoxin qualities. Thus our production process of high purity mineral salts including the use of low endotoxin process water is especially conceptualized for the purpose of the production of parenteral medicines.

 

• LAL test* according to Ph.Eur. is performed on every single batch.

 

• Our customers can optimally integrate our low in endotoxin qualities in their process chain for the manufacture of parenteral dosage forms (please see blue text on the next page).

Products in Low in Endotoxin Quality

Additional products can be developed or lower endotoxin limits (LAL) can be met upon customer request.

See the full brochure on “Mineral Salts Low in Endotoxins” here

(click the picture to download the brochure)

Source: Dr. Paul Lohmann, full brochure “Mineral Salts Low in Endotoxins“

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